QA Specialist - NPI

Overview

Lead QA Specialist - New Product Implementation to provide Quality Assurance leadership for the introduction of new products across a global external manufacturing network. This role includes QA oversight of technology transfer to Contract Manufacturing Organizations (CMOs) and support for external partners manufacturing products for clinical trials and partner studies. You will work in a collaborative, cross-functional environment to ensure compliant, right-first-time delivery of new product introductions in a global, matrixed organization.

• Provide QA oversight for new product introduction (NPI) activities, ensuring compliance with GMP and regulatory requirements.
• Lead QA support for technology transfer to CMOs, including review and approval of protocols and risk assessments.
• Ensure external manufacturing sites are inspection-ready and compliant.
• Act as QA lead for external manufacturing partners, ensuring adherence to quality standards and agreements.
• Review and approve GMP documentation including batch records, deviations, CAPAs, and validation reports.
• Monitor CMO performance through quality metrics, audits, and governance processes.
• Provide QA oversight for manufacture of investigational medicinal products (IMPs) supporting clinical trials.
• Support supply of products to pharmaceutical partners for clinical studies.
• Act as QA interface during client audits and health authority inspections.
• Partner with global cross-functional teams to deliver NPI programs.
• Contribute to project governance, risk management, and decision-making.
• Review documentation ensuring it is clear, accurate, and inspection-ready.
• Apply Quality Risk Management (QRM) principles to mitigate risks.
• Support deviation management and CAPA implementation.
• Drive continuous improvement of NPI and external manufacturing quality processes.
• Conduct on-site visits to CMOs to support technology transfer and QA oversight.
• Travel required:
  
  approximately 10-25% to support external manufacturing activities, audits, and technology transfer.

• Bachelor’s degree in Life Sciences, Pharmacy, Chemistry, or related discipline.
• Experience in Quality Assurance within a GMP-regulated environment.
• Experience in NPI, technology transfer, validation, or external manufacturing.
• Experience working with Contract Manufacturing Organizations (CMOs).
• Knowledge of global regulatory requirements (FDA, EMA, ICH).
• Ability to work in a global, cross-functional matrix environment.
• Strong stakeholder management and influencing skills.
• Solid understanding of GMP and quality systems.
• Strong problem-solving and risk-based decision-making skills.
• Excellent written and verbal communication skills.
• High attention to detail and strong compliance mindset.